14 results · 29ms · Sources: EU EUDAMED, US FDA

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INCLUSIVE TAPERED IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Alleset

FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918179827·Ophthalmic Drape_Full body_Blue SMS Fabric_Inci...

BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES GRENCHEN·Product code HRS·January 30, 2017

MINI-CAP

FDA Adverse Event
Death ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 8, 2013

DEPUY ASR XL FEM IMP SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011

POLYFLUX LR CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

PREVENA PLUS INCISION MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC·Product code OMP·September 24, 2021

PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

FDA Adverse Event
Injury ·CONMED UTICA·Product code GEI·May 18, 2023

AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

FDA Adverse Event
Malfunction ·CONMED UTICA·Product code GEI·May 25, 2023

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023